CoVPN 3003 A Phase 3 Study to Assess the Efficacy and Safety of Ad26.COV2.S for the Prevention of SARS-CoV-2-mediated COVID-19 in Adults Aged 18 Years and Older LC 3

CoVPN 3003 评估 Ad26.COV2.S 在 18 岁及以上成年人中预防 SARS-CoV-2 介导的 COVID-19 的功效和安全性的 3 期研究 LC 3

• 批准号: 10570748
• 负责人: Margaret Juliana McElrath
• 金额: $ 58.69万
• 依托单位: FRED HUTCHINSON CANCER RESEARCH CENTER
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-03-30 至 2022-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10570748
• 关键词: 18 year old; 2019-nCoV; Address; Adenoviruses; Adult; Age-Years; Antibody Response; Antigens; Binding; Biological Assay; Biometry; COVID-19; COVID-19 Prevention Network; COVID-19 outbreak; COVID-19 pandemic; COVID-19 prevention; COVID-19 screening; COVID-19 severity; COVID-19 vaccine; Cellular Assay; Clinical; Clinical Trials; Clinical Trials Network; Cohort Studies; Communicable Diseases; Constitution; Country; Data Analytics; Development; Diagnosis; Disease; Dose; Double-Blind Method; Emergency department visit; End Point Assay; Eye; Future; Goals; HIV Vaccine Trials Network; HIV vaccine; Health; Hospitalization; Immune; Immune response; Immunity; Immunologic Monitoring; Immunology; Individual; Infection; Infection Control; Infection prevention; International; Intervention; Intramuscular; Intramuscular Injections; Knowledge; Laboratories; Latin America; Lead; Leadership; Malaria; Mediating; Medical; Monitor; Morbidity - disease rate; Participant; Persons; Phase; Physicians; Placebo Control; Placebos; Population; Preparation; Prevention; Preventive; Protocols documentation; Quality Control; Randomized; Randomized Clinical Trials; Recombinants; Research Methodology; Risk; SARS-CoV-2 infection; SARS-CoV-2 spike protein; Safety; Sampling; Scientist; Serology test; Serum; Site; South Africa; System; Testing; Therapeutic Monoclonal Antibodies; Typhoid Fever; United States; United States National Institutes of Health; Vaccines; Validation; Viral; adaptive immune response; base; clinical trial analysis; design; efficacy study; efficacy testing; efficacy trial; experience; high risk; immune function; improved; mortality; neutralizing antibody; operation; particle; phase 3 study; prevent; programs; quality assurance; racial and ethnic; racial diversity; rational design; recruit; remote monitoring; response; severe COVID-19; symptomatic COVID-19; vaccine trial; vector; vector vaccine

Project Abstract This proposal outlines the scientific agenda for the COVID-19 Prevention Network (CoVPN) Vaccines Leadership Operations Center (LOC) for implementation of the COVID-19 vaccine efficacy trial entitled “A Randomized, Double-blind, Placebo-controlled Phase 3 Study to Assess the Efficacy and Safety of Ad26.COV2.S for the Prevention of SARS-CoV-2-mediated COVID-19 in Adults Aged 18 Years and Older.” With the global COVID-19 pandemic, we recognize a significant need for vaccines that modify COVID-19 in SARS-CoV-2 infected individuals. Addressing this gap, the National Institutes of Health (NIH) led rapid constitution of the CoVPN, partnering 5 NIH supported clinical trial networks, to create an enhanced network of physician-scientists at 64 United States (US) and 55 international clinical trial sites in 15 countries dedicated to developing globally effective vaccines for SARS-CoV-2. Due to its extensive experience implementing global HIV vaccine trials over the last 20 years, the HIV Vaccine Trials Network (HVTN) LOC was selected as the LOC for CoVPN vaccine trials. This phase 3, placebo-controlled, double-blinded study will test the efficacy of Ad26.COV2.S, a recombinant, replication-incompetent adenovirus type 26 (Ad26) vector constructed to encode the severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) spike (S) protein to modify COVID-19 disease in adults 18 year of age and older. Participants will be recruited from clinical trial sites across the US, Latin America and South Africa using data analytics to target high risk individuals with a diverse racial and ethnic profile. Participants will receive symptomatic screening for SARS-CoV-2 infection, and if they become infected will be monitored with frequent clinical check-ins and remote monitoring of vital signs. Infected individuals who progress to moderate-severe COVID-19 will be referred for hospitalization. All trial endpoint assays will be done using qualified and validated assays for diagnosis and immune monitoring. Specific aims of this study are to demonstrate efficacy of Ad26.COV2.S to prevent COVID-19, to evaluate the safety, tolerability and reactogenicity of one intramuscular (IM) injection of 1x1011 viral particles (vp) or placebo, to assess the ability to prevent infection with SARS-CoV-2, to assess the ability to modify COVID-19 disease, to assess the ability to prevent emergency room visits, and to evaluate the binding and neutralizing antibody responses. This efficacy trial will tell us much about the adaptive immune response in persons who receive a SARS-CoV-2 S protein-based vaccine and about their ability to modify the disease course of COVID-19. In addition, it will improve our understanding of the dynamics and duration of these immune responses and will inform rational design and testing of preventive and therapeutic monoclonal antibody interventions. Lastly, the results of this trial will be used to assess registration of this vaccine product as well as to modify future COVID- 19 vaccine trials planned over the next 12 months.

项目摘要 该提案概述了COVID-19预防网络（COVPN）疫苗领导力的科学议程 用于实施Covid-19疫苗效率试验的操作中心（LOC），标题为“随机， 双盲，安慰剂控制的第三阶段研究，以评估AD26.COV2.2的功效和安全性 预防18岁及以上的成年人SARS-COV-2介导的COVID-19。” 随着全球COVID-19的大流行，我们认识到对修改Covid-19的疫苗的重要需求 SARS-COV-2感染的个体。解决这一差距，美国国立卫生研究院（NIH）领导了快速 COVPN的配置，与5个NIH支持的临床试验网络合作，以创建一个增强的网络 美国64（美国）和55个国际临床试验地点的物理科学家在15个国家 /地区致力于 为SARS-COV-2开发全球有效的疫苗。由于其广泛实施全球的经验 HIV疫苗试验在过去20年中，选择了HIV疫苗试验网络（HVTN）LOC作为LOC 用于COVPN疫苗试验。 该第3阶段，安慰剂对照，双盲研究将测试AD26.COV2.S的效率，重组， 构建用于编码严重急性呼吸的26型腺病毒26型腺病毒（AD26） 综合征冠状病毒-2（SARS-COV-2）尖峰蛋白，以修饰18岁的成年人的COVID-19疾病 又年龄较大。参与者将从美国，拉丁美洲和南部的临床试验地点招募 非洲使用数据分析来针对具有多样性种族和种族形象的高风险个人。 参与者将接受SARS-COV-2感染的症状筛查，如果感染， 通过经常进行临床检查和对生命体征的远程监测进行监测。受感染的人 将转置为中期的Covid-19将被转交给住院。所有试验端点测定都将完成 使用合格且经过验证的测定法进行诊断和免疫监测。 这项研究的具体目的是证明AD26.COV2.S防止Covid-19的效率，以评估 1x1011病毒颗粒（VP）或安慰剂的一项肌肉内（IM）注射的安全性，耐受性和反应生成性， 为了评估防止SARS-COV-2感染的能力，评估改变Covid-19疾病的能力， 评估防止急诊室就诊的能力，并评估结合和中和抗体 回答。这项效率试验将向我们介绍收到一个人的适应性免疫响应 SARS-COV-2 S蛋白基疫苗以及它们改变Covid-19的疾病过程的能力。在 此外，它将提高我们对这些免疫反应的动态和持续时间的理解，并将 信息理性的设计和预防和治疗性单克隆抗体干预的测试。最后， 该试验的结果将用于评估该疫苗产品的注册，并修改未来的covid- 在接下来的12个月内计划进行19次疫苗试验。